China NMPA Product Recall - Disposable locking blood collection device

Becton Dickinson and Company (BD) initiated a voluntary Class II recall for specific single-use lock-on blood collection devices, as reported by the National Medical Products Administration (NMPA) on March 27, 2019. The core issue involved a manufacturing defect where the non-patient end of the device's needle had a missing beveled section. This critical flaw could potentially damage the sealing sleeve, leading to leakage and hindering the proper insertion of the needle into vacuum blood collection tubes during clinical blood collection procedures. The company, including its Chinese subsidiary BD Medical Devices (Shanghai) Co., Ltd., operates under the NMPA's regulatory framework, evidenced by the National Medical Device Registration Certificate 20173151684. The recall was prompted by reports from overseas customers, primarily affecting products sold in the USA and Canada. Importantly, the detailed recall event report confirmed that the identified affected product batches were neither imported into nor sold within China. Therefore, the regulatory documentation explicitly stated that no corrective actions or handling measures were required for products within the Chinese market.